(73 days)
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (.36 mm) or 0.018 in (.46 mm) guidewires.
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire (OTW) catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guide wires 0.014 in or 0.018 in (.36 mm or .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon.
The balloon lengths are available in 120, 150, 200 and 220 mm sizes with diameters of 5.0, 6.0 and 7.0 mm for each balloon length.
The effective lengths of the balloon catheter are 90 cm and 150 cm. Markers on the 90 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 150 cm effective length catheter indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock port for guidewire lumen.
The provided text describes the Sterling OTW PTA Balloon Dilatation Catheter and its performance testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific numerical acceptance criteria for each test. Instead, it states that "The Sterling OTW PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate." This implies that the acceptance criteria were defined by the performance of the predicate device and/or industry standards for such devices.
Therefore, the table will reflect the categories of tests performed and the general statement of performance:
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | MEM Elution Cytotoxicity | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate |
| Hemocompatibility (Direct Contact) | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate | |
| Chemical Characterization-USP Physicochemical | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate | |
| Natural Rubber Latex | Conformance to ISO 10993-1 for short duration contact with blood | Met acceptance criteria, results similar to predicate | |
| Bench (In-vitro) | Bond Integrity | Performance similar to predicate | Met acceptance criteria, results similar to predicate |
| Working Length | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Deflation Time | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Rated Burst Pressure (RBP) | Same as predicate | Met acceptance criteria, results similar to predicate (Same RBP) | |
| Balloon Multiple Inflation | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Crossing Profile | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Full Catheter Tensile Extension and Deflation | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Multiple Inflation in a Stent | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Particulate Evaluation | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Proximal Balloon Bond and Shaft Tensile Strength | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Burst Mode | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Compliance | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Nominal Diameter | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Burst in a Stent | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Balloon Body Length | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Guidewire Movement | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Sheath Withdrawal | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Marker Band to Balloon Alignment | Performance similar to predicate | Met acceptance criteria, results similar to predicate | |
| Torque after Conditioning | Performance similar to predicate | Met acceptance criteria, results similar to predicate |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size (number of devices or tests) used for the bench and biocompatibility testing. It only states that these tests were "performed."
- Data Provenance: The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given the context of a 510(k) summary for a medical device submitted to the FDA (indicating "BOSTON SCIENTIFIC CORPORATION" in Maple Grove, MN, USA), it can be inferred that the testing was likely conducted in the USA (or by a US-affiliated entity) and was prospective for the purpose of this submission. The tests are general performance and biocompatibility tests, not clinical data sets in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable to the type of information presented. The performance assessment for this device is based on bench testing and biocompatibility testing, not on the interpretation of medical images or diagnostic outputs that would require human expert consensus as ground truth. The "ground truth" for these tests would be the established engineering specifications and biological safety standards.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation is based on objective measurements from bench testing and laboratory analysis for biocompatibility, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done for this device. This type of study involves human readers interpreting data, often medical images, to assess the impact of an AI system. The Sterling OTW PTA Balloon Dilatation Catheter is a physical medical device, not an AI or diagnostic imaging tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is not an algorithm or an AI system. Its performance is assessed through physical bench tests and biological assays.
7. Type of Ground Truth Used:
The ground truth for the performance data in this submission is based on:
- Established engineering specifications and design requirements: For bench testing (e.g., burst pressure, dimensions, tensile strength).
- International standards for biocompatibility (ISO 10993-1): For biocompatibility testing.
- Performance of the predicate device: The new device was required to perform "similar to the predicate."
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device and does not involve AI or machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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K132430 .p. 1 of 4
510(k) Summary
per 21 CFR §807.92
OCT 1 7 2013
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact NameandInformation | Christopher DachelSenior Regulatory Affairs SpecialistPhone: 763-494-2718Fax: 763-494-2222e-mail: dachelc@bsci.com |
| Date Prepared | 17 October 2013 |
| ProprietaryName | Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter |
| Common Name | Percutaneous Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter |
| PredicateDevice(s) | Sterling OTW PTA Balloon Dilatation Catheter, K053116, December 16, 2005 |
| DeviceDescription | The Sterling OTW Percutaneous Transluminal Angioplasty (PTA) BalloonDilatation Catheter is a high performance balloon catheter for peripheralindications. The device features an ultra low profile, semi-compliantballoon combined with a low profile tip. The catheter is compatible witheither 0.014 in (.36 mm) or 0.018 in (.46 mm) guidewires.The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire(OTW) catheter with a semi-compliant balloon fixed at the distal tip. Theballoon catheter has a coaxial shaft design. The outer lumen is used forinflation of the balloon, and the wire lumen permits the use of guide wires0.014 in or 0.018 in (.36 mm or .46 mm) to facilitate advancement of thecatheter to and through the stenosis to be dilated. The balloon is designedto provide an inflatable segment of known diameter and length atrecommended pressures. The catheter includes a tapered tip to facilitateadvancement of the catheter to and through the stenosis. Two radiopaquemarker bands (one proximal and one distal), in conjunction withfluoroscopy, enable accurate positioning of the balloon.The balloon lengths are available in 120, 150, 200 and 220 mm sizes withdiameters of 5.0, 6.0 and 7.0 mm for each balloon length.The effective lengths of the balloon catheter are 90 cm and 150 cm.Markers on the 90 cm effective length catheter indicate the exit of thedilatation catheter tip out of the guiding catheter (one at 50 cm and two at60 cm). Markers on the 150 cm effective length catheter indicate the exit ofthe dilatation catheter tip out of the guiding catheter (one at 90 cm and twoat 100 cm). The proximal portion of the catheter includes one female Luer-lock port connected to the inflation lumen, and one female Luer-lock portfor guidewire lumen. |
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| Intended Use/Indications forUse of Device | The Sterling OTW PTA Balloon Dilatation Catheter is indicated forPercutaneous Transluminal Angioplasty (PTA) in the peripheralvasculature, including iliac, femoral, popliteal, infra-popliteal, and renalarteries, and for the treatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheralvasculature. |
|---|---|
| --------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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(
Comparison of Technological Characteristics
The Sterling OTW PTA Balloon Dilatation Catheter will incorporate a substantially equivalent design, packaging, fundamental technology, materials, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling OTW Balloon Dilatation Catheter.
| Comparison to Predicate Device in Materials and Manufacturing | |
|---|---|
| --------------------------------------------------------------- | -- |
| Characteristic | Comparison to Sterling OTW Predicate |
|---|---|
| Manifold | Same material. Same design serving the same function. |
| Manifold Bond Adhesive | Same material. Same design serving the same function. |
| Strain Relief | Same material. Same design serving the same function. |
| Corewire | Same material. Same design serving the same function. |
| Outer Shaft | Same material. Same design serving the same function. |
| Inner Shaft | Same material. Same colorants. Same design serving the same function. |
| Balloon | Same material. Same design serving the same function and fundamental technology. |
| Markerbands | Same component serving the same function. |
| Proximal Marks | Same material. Same design serving the same function. |
| Coating | Same coating serving same function. |
| Bumper Tip | Same material. Same colorant. Same design serving the same function. |
| Sterilization Method | Same method |
| SAL | Same level of assurance |
| Balloon Diameters | Diameters within the predicate diameter range, service the same function. |
| Balloon Lengths | Additional balloon lengths; 120, 150, 200, and 220 mm |
| Usable Catheter Lengths | Additional catheter lengths; 90 and 150 cm |
| Rated Burst Pressure(RBP) | Same Rated Burst Pressure |
| RecommendedIntroducer SheathCompatibility | Sheath compatibility within the predicate compatibility range, same function |
| RecommendedGuidewire | Same compatability |
| Packaging | Same function and design |
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| PerformanceData | Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. TheSterling OTW PTA Balloon Dilatation Catheter met all acceptance criteriafor the bench and biocompatibility testing with results similar to thepredicate. No new safety or performance issues were raised during thetesting and, therefore, these devices may be considered substantiallyequivalent to the predicate devices. | ||||
|---|---|---|---|---|---|
| The following biocompatibility and bench testing were completed on theSterling OTW PTA Balloon Dilatation Catheter:BiocompatibilityThe device was tested for biocompatibility per ISO 10993-1 for shortduration contact with blood (<24 hours). The testing included MEM ElutionCytotoxicity, Hemocompatibility (Direct Contact), ChemicalCharacterization-USP Physicochemical, and Natural Rubber Latex | |||||
| The following in-vitro performance tests were completed on the SterlingOTW PTA Balloon Dilatation Catheter: | |||||
| Bench | |||||
| Bond Integrity | Balloon Burst Mode | ||||
| Working Length | Balloon Compliance | ||||
| Deflation Time | Balloon Nominal Diameter | ||||
| Balloon Rated Burst Pressure (RBP) | Burst in a Stent | ||||
| Balloon Multiple Inflation | Balloon Body Length | ||||
| Crossing Profile | Guidewire Movement | ||||
| Full Catheter Tensile Extensionand Deflation | Sheath Withdrawal | ||||
| Balloon Multiple Inflationin a Stent | Marker Band to BalloonAlignment | ||||
| Particulate Evaluation | Torque after Conditioning | ||||
| Proximal Balloon Bond andShaft Tensile Strength | |||||
| Conclusion | Based on the Indications for Use, technological characteristics, safety andperformance testing, the Sterling OTW PTA Balloon Dilatation Catheter hasbeen shown to be appropriate for its intended use and is considered to besubstantially equivalent to the Sterling OTW PTA Balloon DilatationCatheter (K053116 cleared December 16, 2005). |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human form. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2013
Boston Scientific Corporation Mr. Christopher Dachel Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K132430
Trade/Device Name: Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 22, 2013 Received: August 23, 2013
Dear Mr. Dachel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Christopher Dachel
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram DZuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center_for_Devices_and_Radiological_Health_
Enclosure
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Indications for Use
510(k) Number (if known): _ K132430
Device Name: Sterling™ Over-the-Wire™ (OTW) PTA Balloon Dilatation Catheter
Indications for Use:
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram 2013.1
Boston Scientific Corporation
Page 1 of 1
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).